Signature Versus Computer Assisted Surgery Study

NCT ID: NCT01256216

Last Updated: 2017-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2016-05-31

Brief Summary

The purpose of the data collection is to document the performance and clinical outcomes of the Vanguard Knee using Signature Custom Cutting Guides and Computer Assisted Surgery.

Detailed Description

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard® Knee System using Signature™ Custom Guides and Computer Assisted Surgery.

FDA has cleared the Vanguard Knee via premarket notification 510(k) K023546, K033489, and K050222. FDA has cleared the software for the Signature™ Custom Guides via premarket notification 510(k) K073449. The data gathered will be collated and used to provide feedback to design engineers, support marketing efforts, answer potential questions from reimbursement agencies, and will serve as a part of Biomet's Post Market Surveillance System.

Function will be assessed through the Knee Society Score. Survivorship will be documented by asking the surgeon to document revisions and complications.

Conditions

Joint Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Signature Custom Cutting Guides

Patients receiving a Vanguard Total Knee implanted utilizing non implantable Signature Cutting Guides Surgical Technique.

Group Type: OTHER

Total Knee Replacement with Vanguard Total Knee

Intervention Type: DEVICE

Patients indicated for a total knee replacement utilizing the Vanguard Total Knee System.

CAS (Computer Assisted Surgery)

Patients receiving a Vanguard Total Knee implanted utilizing non implantable Computer Assisted Surgery Technique.

Group Type: OTHER

Total Knee Replacement with Vanguard Total Knee

Intervention Type: DEVICE

Patients indicated for a total knee replacement utilizing the Vanguard Total Knee System.

Interventions

Total Knee Replacement with Vanguard Total Knee

Patients indicated for a total knee replacement utilizing the Vanguard Total Knee System.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

These indications are stated below:

• Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
• Correction of varus, valgus, or posttraumatic deformity.
• Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
• The Regenerex™ femoral augments are indicated for use with the Vanguard® Total Knee System.
• The Regenerex™ tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.

Patient selection factors to be considered include:

• Need to obtain pain relief and improve function
• Ability and willingness of the patient to follow instructions, including control of weight and activity level
• A good nutritional state of the patient, and
• The patient must have reached full skeletal maturity
• Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok™) devices and all polyethylene patellar components are indicated for cemented application only.

Exclusion Criteria

• Absolute contraindications include: infection, sepsis, and osteomyelitis
• Relative contraindications include:
• Uncooperative patient or patient with neurologic disorders who is incapable of following directions
• Osteoporosis
• Metabolic disorders which may impair bone formation,
• Osteomalacia
• Distant foci of infections which may spread to the implant site
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
• Vascular insufficiency, muscular atrophy, neuromuscular disease
• Incomplete or deficient soft tissue surrounding the knee.
• Biomet® Microplasty™ Tibial Trays are contraindicated for use with constrained bearings.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Russell A Schenck, PhD

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

Russells Hall Hospital

Dudley, , United Kingdom

Countries

United Kingdom

Other Identifiers

121509

Identifier Type: -

Identifier Source: org_study_id